EPI-7386 Early/Expanded Access Policy
ESSA Pharma, Inc. is a clinical-stage drug development company that has begun development of a second generation “-aniten” compound (EPI-7386) for the treatment of metastatic castration-resistant prostate cancer resistant to current standard of care. The drug is currently under evaluation in a Phase 1 clinical trial (ClinicalTrials.gov Identifier: NCT04421222).
Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug.
ESSA Pharma’s goal is to provide access for patients to our investigational therapy at an appropriate time during the drug development process. ESSA believes that investigational drugs should be primarily evaluated in patients as part of clinical trials designed to obtain data on drug safety and efficacy. The data from these trials may then ultimately be used to support approval by regulatory agencies of the product and consequent wider accessibility to patients. Regulators will only authorize a new medicine if these trials, together with other research data, demonstrate a medicine has a favorable risk benefit profile when used in a defined and controlled clinical setting. We encourage patients to speak with their physicians and to participate in clinical trials, when appropriate and if eligible.
With respect to the requested use of ESSA investigational agents outside of the controlled clinical trial setting, ESSA recognizes that not every patient who wishes to participate in a clinical trial will meet the eligibility criteria. In rare cases when patients with serious diseases are unable to participate in clinical trials and have exhausted all available therapies, ESSA Pharma may consider providing an investigational drug outside of a clinical trial. As a general policy, ESSA will not provide investigational drug until sufficient preliminary safety and efficacy information has been obtained in clinical trials, typically following the completion of Phase 2 investigation and after consultation with regulatory agencies. As mentioned above, EPI-7386 is currently undergoing evaluation in early clinical development.
If you are a patient who is interested in accessing EPI-7386, please first speak with your physician. You may also learn more about our ongoing clinical trial by going to www.clinicaltrials.gov and searching for the clinical trial identified NCT04421222.
If you are a physician who is interested in learning more about our investigational drug, please submit a request to [email protected].
If you are a treating physician, who believes your patient meets the criteria detailed below, and would like to submit requests for expanded access, please submit your query to [email protected]. Please note that requests for expanded access must be made by the physician responsible for treating the patient for cancer, and each request needs to relate to a single patient, including sufficient supporting detail to enable ESSA Pharma to evaluate the expanded access request.
General Criteria: ESSA Pharma will evaluate and respond to a request that it receives on a case-by-case basis, applying the following criteria:
- The illness being treated is serious and life threatening, and there are no marketed treatment alternatives
- There must be adequate supply of the investigational product(s) to meet the needs of the expanded access program without impairing ongoing clinical trials
- There is a good understanding of the actions of the investigational drug in the indication for which use is requested, and sufficient clinical data to identify an appropriate dose and treatment regimen, as well as a likelihood of benefit relative to potential risks
This posting of the policy shall not serve as a guarantee of access to any specific investigational drug for any patient
In the U.S. physicians may find additional information regarding expanded access to investigational therapies by visiting the U.S. Food and Drug Administration website: Expanded Access: Information for Physicians.
Non-U.S. physicians must follow local laws and regulations appropriate for the country originating the request.